510(k) K110001 ยท DQK Computer, Diagnostic, Programmable
SPACELABS PATHFINDER SL HOLTER ANALYZER
| Applicant | Spacelabs Healthcare, Ltd., Nederland CO, US |
| Decision | Substantially Equivalent, Jun 14, 2011 |
| Received | Jan 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110001
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2012 | Spacelabs Healthcare, Llc The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0.
Product Usage:
The Holter Analyzer analyzes information coll Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.